Balloon catheter

ABSTRACT

A balloon catheter having an elongated catheter shaft defining a fluid drainage lumen and a balloon inflation lumen. The balloon catheter includes a fluid drainage port disposed about the distal end of the catheter shaft in fluid communication with the fluid drainage lumen, and a balloon inflation port disposed about the distal end of the catheter shaft in fluid communication with the balloon inflation lumen. A balloon portion is disposed about the distal end of the catheter shaft in fluid communication with the balloon inflation port. A release device is disposed in fluid communication with the balloon portion and the fluid drainage lumen, and includes an activating member. A tether is attached to the activating member of the release device. Tension applied to the tether activates the release device, enabling fluid flow from the balloon portion into the fluid drainage lumen and out of the body.

TECHNICAL FIELD

The subject disclosure relates to medical devices, and more particularlyrelates to balloon catheters that can be inserted into a vessel of ahuman body to perform medical procedures. The subject disclosure isparticularly relevant to minimizing the damage caused to a human bodywhen an inflated balloon catheter is removed from a vessel in the body.

BACKGROUND

By way of background concerning some conventional systems, ballooncatheters, such as urinary catheters, can be used for a variety ofmedical procedures, including drainage of bodily fluids. Conventionalurinary catheters, such as Foley catheters, can provide a channel forvoiding fluid contained by the urinary bladder. Foley catheters areconventionally designed to be inserted into the urethral meatus andadvanced through the urethra into the urinary bladder. They can containa catheter tip with a balloon (e.g., retention balloon or anchorballoon), a fluid drainage lumen for draining urine from the urinarybladder, and a balloon inflation lumen for inflating or deflating theballoon. Conventionally, the portion of the Foley catheter including thecatheter tip and balloon is advanced into the urinary bladder, at whichpoint an inflation device can be used to insert fluid through theballoon inflation lumen and into the attached balloon, causing theballoon to inflate, securing the Foley catheter in place. In order toremove the Foley catheter from the bladder, fluid is conventionallywithdrawn from the balloon through the balloon inflation lumen, causingthe balloon to deflate. Once deflated, the Foley catheter can beretracted from the urinary bladder through the urethra, and removed fromthe human body.

However, the use of Foley catheters and other balloon catheters carrieswith it a variety of deficiencies. One such deficiency conventionallyassociated with the use of a Foley catheter is urethral injury resultingfrom removal of the Foley catheter with a fully- or partially-inflatedballoon (e.g., inflated Foley catheter), such as when tension is appliedto the portion of the Foley catheter outside the human body. Withsufficient tension, the inflated Foley catheter balloon can be pulledthrough the urethra (e.g., traumatic Foley catheter removal), resultingin urethral injury, mucosal tears and lacerations, hematuria, orurethral disruption, and can lead to urethral strictures and scarformation causing subsequent urinary tract obstruction. Traumatic Foleycatheter removal can also disrupt or damage the urethral sphincterswhich may lead to permanent urinary incontinence. Furthermore, removalof an inflated Foley catheter can result in significant penile injury inmales and complete bladder eversion in women. The problem of traumaticFoley catheter removal is common, and is a frequent indication forurologic consultation. Traumatic Foley catheter removal is classicallyperformed by patients having diminished mental capacity, includingdementia or delirium, but can occur in any patient population.Unintentional removal can also occur as a result of tripping over orstepping on catheter tubing external to the body, or as a result oftransferring patients from one location to another, as is common duringsurgery.

Another deficiency conventionally associated with the use of a Foleycatheter is the potential for a non-deflating balloon, which complicatescatheter removal. According to some reports, the deficiency of anon-deflating balloon has been observed in approximately eight to ninepercent of latex Foley catheters. A non-deflating balloon can have avariety of causes, including defective valves in the balloon inflationlumen, solute crystal formation in the balloon inflation lumen, orkinking of the Foley catheter that compromises the balloon inflationlumen.

An even further deficiency conventionally associated with the use of aFoley catheter is tissue trauma caused by an increase in pressure aboutthe balloon when an inflated balloon is translumenally or percutaneouslyruptured in order to remove the catheter from the human body. This canlead to the problem of retained balloon fragments within the urethra orbladder, which can encourage infection and calculus formation (e.g.,lithiasis), potentially resulting in partial or complete urinaryobstruction and recurrent urinary tract infections.

The above-described deficiencies of today's Foley catheters and otherballoon catheters are merely intended to provide an overview of some ofthe problems of conventional systems, and are not intended to beexhaustive. Other problems with the state of the art and correspondingbenefits of some of the various non-limiting embodiments may becomefurther apparent upon review of the following detailed description.

SUMMARY

A simplified summary is provided herein to help enable a basic orgeneral understanding of various aspects of exemplary, non-limitingembodiments that follow in the more detailed description and theaccompanying drawings. This summary is not intended, however, as anextensive or exhaustive overview. Instead, the sole purpose of thissummary is to present some concepts related to some exemplarynon-limiting embodiments in a simplified form as a prelude to the moredetailed description of the various embodiments that follow.

A balloon catheter is provided that can be inserted through a vesselinto a human body to perform medical procedures. The balloon cathetercan include an elongated catheter shaft defining a fluid drainage lumenand a balloon inflation lumen. The catheter shaft can have a proximalend portion and a distal end portion. A port can be disposed at thedistal end portion of the catheter shaft such that the port is in fluidcommunication with the fluid drainage lumen. A balloon can be disposedat the distal end portion of the catheter shaft such that the balloon isin fluid communication with the balloon inflation lumen. A tensionactivated release valve can be disposed between the balloon and thefluid drainage lumen, for releasing fluid from the balloon into thefluid drainage lumen when tension is applied to the catheter shaft.

These and other embodiments are described in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

Various non-limiting embodiments are further described with reference tothe accompanying drawings in which:

FIG. 1 is a schematic perspective view of a balloon catheter accordingto an embodiment with a deflated balloon, with a cross-sectional sideview of the distal end portion;

FIG. 2 is a schematic cross-sectional side view of a balloon catheteraccording to an embodiment inserted into a vessel, illustrating fluidpassing through the balloon inflation lumen into the balloon, causing itto inflate;

FIG. 3 is a schematic cross-sectional side view of a balloon catheteraccording to an embodiment inserted into a vessel, illustrating fluidpassing from the balloon through a tension activated release valve andinto a fluid drainage lumen, causing the balloon to deflate;

FIG. 4 is a schematic cross-sectional side view of the distal endportion of a balloon catheter according to an embodiment, having anopen-ended catheter tip;

FIG. 5 is a schematic cross-sectional side view of the distal endportion of a balloon catheter according to an embodiment, having atension activated flap release device;

FIG. 6 is a schematic cross-sectional side view of the distal endportion of a balloon catheter according to an embodiment, having atension activated gate valve release device; and

FIG. 7 is a schematic system block diagram of a balloon catheteraccording to an embodiment.

DETAILED DESCRIPTION Overview

The claimed subject matter is now described with reference to thedrawings, wherein like reference numerals are used to refer to likeelements throughout. In the following description, for purposes ofexplanation, numerous specific details are set forth in order to providea thorough understanding of the claimed subject matter. It may beevident, however, that the claimed subject matter may be practicedwithout these specific details. In other instances, well-knownstructures and devices are shown in block diagram form in order tofacilitate describing the claimed subject matter.

As used in this application, the terms “catheter,” “balloon catheter,”“urinary catheter,” “Foley catheter” or the like can refer to a flexibletube inserted into the human body to introduce or withdraw fluids.

Moreover, the word “exemplary” is used herein to mean serving as anexample, instance, or illustration. Any aspect or design describedherein as “exemplary” is not necessarily to be construed as preferred oradvantageous over other aspects or designs. Rather, use of the wordexemplary is intended to present concepts in a concrete fashion. As usedin this application, the term “or” is intended to mean an inclusive “or”rather than an exclusive “or.” Therefore, unless specified otherwise, orclear from context, “X employs A or B” is intended to mean any of thenatural inclusive permutations. That is, if X employs A; X employs B; orX employs both A and B, then “X employs A or B” is satisfied under anyof the foregoing instances. In addition, the articles “a” and “an” asused in this application and the appended claims should generally beconstrued to mean “one or more” unless specified otherwise or clear fromcontext to be directed to a singular form.

As discussed in the background, among other things, current Foleycatheters and other balloon catheters tend to cause urethral injury whenremoved in a fully- or partially-inflated state, tend to exhibitnon-deflating balloons that complicate catheter removal, and tend tocause tissue trauma and retained foreign particles (e.g., balloonfragments) when an inflated balloon is ruptured in order to remove thecatheter from a human body.

At least partly in consideration of these deficiencies of conventionalFoley catheters and other balloon catheters, various embodiments of aballoon catheter are provided that provide a way for fluid contained byan inflated balloon of a balloon catheter to be released into a fluiddrainage lumen out of the body, aiding in removal of the ballooncatheter from a human body. As noted herein, various release devices canbe employed to release fluid contained by an inflated balloon of aballoon catheter into a fluid drainage lumen out of the body.

Details of various other exemplary, non-limiting embodiments areprovided below.

Balloon Catheter

The present invention describes an apparatus and method for deflating aballoon catheter apparatus. According to an exemplary embodiment, theballoon catheter includes a release device disposed between a balloonportion and a fluid drainage lumen of the balloon catheter. The releasedevice allows the balloon catheter having an inflated balloon portion tobe removed from a vessel in a human body without causing trauma tosurrounding tissue, by releasing fluid from the balloon whenlongitudinal force (e.g., tension) is applied to the catheter shaft.When tension is applied to the portion of the balloon catheter outsidethe human body, the catheter shaft lengthens as the inflated balloonportion resists removal from the vessel in which it is positioned. Whenthe shaft lengthens a predetermined amount, the release device isenabled to rapidly release fluid from the balloon portion into the fluiddrainage lumen and out of the body. With fluid released from the balloonportion, the balloon portion deflates and the catheter can be safelyremoved without causing urethral injury. According to an exemplaryembodiment, one end of a tether is attached to an activating member ofthe release device, while the other end of the tether is attached aboutthe portion of the catheter shaft outside the human body. Tensionapplied to the relatively elastic catheter shaft causes the relativelyinelastic tether to pull on the activating member of the release device,enabling the release device to rapidly release fluid from the balloonportion into the fluid drainage lumen and out of the body. In oneparticular embodiment, an open-ended (e.g., hollow ended) catheter tipcan be employed for enabling urine to freely pass from the bladder intothe catheter, in the event that the catheter is only partially withdrawnfrom the body, and the tip remains located within the urethra.

Referring now to the drawings, with reference initially to FIG. 1, aballoon catheter apparatus 10 according to an exemplary embodiment caninclude an elongated catheter shaft 20 defining a fluid drainage lumen30 and a balloon inflation lumen 40. The catheter shaft 20 has aproximal end portion 22 about the proximal end and a distal end portion24 about the distal end. A catheter tip 21 is disposed at the distal endof the catheter shaft 24. The catheter shaft 20 can be flexible tofacilitate insertion and removal of the catheter shaft 20 from channelsin a human body. In particular, the catheter shaft 20 can be flexible tofollow the natural curvature of the urethra when the catheter shaft 20is inserted through the urethral meatus and advanced through the urethraand into the urinary bladder. The catheter shaft 20 can be elastic(e.g., extendable), such that the length of the catheter shaft 20 can beextended by applying tension to one end of the catheter shaft 20 whilethe other end of the catheter shaft 20 remains substantially stationary(e.g., stretching the catheter shaft). According to an exemplaryembodiment, the catheter shaft 20 may be extended when the distal endportion 24 is secured inside a vessel (e.g., secured by an inflatedballoon), and tension (e.g., longitudinal force) is applied to theproximal end portion 22 of the catheter shaft 20, in a direction awayfrom the distal end portion 24.

According to an exemplary embodiment, the distal end portion 24 caninclude a fluid drainage port 32 in fluid communication with the fluiddrainage lumen 30. As shown in FIGS. 2 and 3, the catheter shaft 20 canbe inserted into a vessel (e.g., the urinary bladder) so that the fluiddrainage port 32 is in fluid communication with the vessel. Fluid (e.g.,urine) in the vessel can travel through the fluid drainage port 32, intothe fluid drainage lumen 30, and out of the body. The proximal endportion 22 of the catheter shaft 20 may have a drainage connector 34 influid communication with the fluid drainage lumen 30. The drainageconnector 34 can be used to direct fluid from the fluid drainage lumen30 into a collection or disposal apparatus, such as a urine storage bag.

As shown in FIG. 1, a balloon inflation port 42 can be disposed aboutthe distal end portion 24 of the catheter shaft 20 according to anembodiment, such that the balloon inflation port 42 is in fluidcommunication with the balloon inflation lumen 40. The balloon inflationport 42 can be positioned in a spaced apart configuration from the fluiddrainage port 32.

A balloon portion 50 can be disposed about the distal end portion 24 ofthe shaft, such that the balloon portion 50 is in fluid communicationwith the balloon inflation port 42. In one exemplary embodiment, theballoon portion 50 can be disposed between the fluid drainage port 32and the proximal end portion 22 of the shaft. The balloon portion 50 canbe constructed from a deformable or elastic membrane (e.g., latex,silicone) that surrounds a longitudinal section of the catheter shaft20. The balloon portion 50 can also be sealed to a longitudinal sectionof the catheter shaft 20, so that fluid can be contained between theballoon portion 50 and the catheter shaft 20. The balloon portion 50 canbe radially inflated in response to positive pressure of fluidcommunicated into the balloon portion 50 through the balloon inflationlumen 40.

The proximal end portion 22 of the catheter shaft 20 may include aballoon inflation connector 46 in fluid communication with the ballooninflation lumen 40. The balloon inflation connector 46 can be connectedto a balloon inflation device. The balloon inflation device can be usedto inflate or deflate the balloon portion 50. In an exemplaryembodiment, the balloon inflation device can be a piston pump, such as asyringe. When the balloon inflation device is connected to the ballooninflation connector, fluid (e.g., air, saline) expelled from the ballooninflation device travels through the balloon inflation lumen 40 and intothe balloon portion 50, causing the balloon portion 50 to inflate. In anexemplary embodiment, a valve may be placed in the balloon inflationconnector 46 or in the balloon inflation lumen 40 to prevent the releaseof fluid back through the balloon inflation connector 46 when theballoon inflation device is removed from the balloon inflation connector46. In order to deflate the balloon portion 50, a balloon inflationdevice can be attached to the balloon inflation connector 46, and fluidfrom the balloon portion 50 can be drawn into the balloon inflationdevice through the balloon inflation lumen 40, causing the balloonportion 50 to deflate.

According to an exemplary embodiment, a pressure release port 44 can bedisposed at the distal end portion 24 of the catheter shaft 20, betweenthe balloon inflation lumen 40 and the fluid drainage lumen 30, suchthat the pressure release port 44 places the balloon inflation lumen 40in fluid communication with the fluid drainage lumen 30. The pressurerelease port 44 can be disposed longitudinally along the ballooninflation lumen 40 between the balloon inflation port 42 and thecatheter tip 21. In an exemplary embodiment, the catheter tip 21 can beopen-ended (e.g., hollow), as shown in FIG. 4. The catheter tip 21 canbe open to the fluid drainage port 32, such that fluid can pass throughthe fluid drainage port 32 in the catheter tip 21 and into the fluiddrainage lumen 30. Moreover, it should be appreciated that the pressurerelease port 44 can be located between the balloon inflation lumen 40and the fluid drainage lumen 30 at any location between the ballooninflation port 42 and the distal end of the catheter shaft 20. In oneexemplary embodiment, the pressure release port 44 can be located at thedistal end of the catheter shaft 20, such that the pressure release port44 is a notch between the balloon inflation lumen 40 and the fluiddrainage lumen 30.

As shown in FIGS. 1 through 7, a release device 60 can be disposedbetween the balloon portion 50 and the fluid drainage lumen 30, forselectively releasing fluid from the balloon portion 50 into the fluiddrainage lumen 30, and out of the body. The release device 60 cancomprise an activating member, for enabling fluid flow through therelease device. A substantially non-elastic (e.g., substantiallynon-extendable) tether 62 can be affixed to the activating member, formanipulating the position of the activating member to activate therelease device 60. According to an exemplary embodiment shown in FIGS. 1through 4, the activating member can comprise a plug 61 within theballoon inflation lumen 40, positioned between the balloon inflationport 42 and the catheter tip 21. The substantially non-elastic tether 62can be affixed to the plug 61 and extend through the balloon inflationlumen 40 toward the proximal end portion of the catheter shaft 22. In adisabled state, the plug 61 substantially seals the balloon inflationlumen 40 so that fluid within the balloon inflation lumen 40 on one sideof the plug 61 is unable to flow past the plug 61 and through theballoon inflation lumen 40 to the pressure release port 44. It should beunderstood that the release device 60 could include any device having anactivating member (e.g., valve, flap) suitable for controlling the flowof a liquid.

According to an exemplary embodiment as shown in FIG. 5, the releasedevice 60 can comprise a pressure release port 44 covered by a flexibleflap 64 that serves as an activating member, for placing the balloonportion 50 in fluid communication with the fluid drainage lumen 30 whenthe flap 64 is pulled away from the pressure release port 44. Asubstantially non-elastic tether 62 can be affixed to the activatingmember (e.g., the flap 64) and extend through the balloon inflationlumen 40 in a direction toward the proximal end portion of the cathetershaft 22. In a disabled state, the flap 64 prevents fluid in the balloonportion 50 from flowing past the flap 64, through the pressure releaseport 44 and into the fluid drainage lumen 30. In an enabling position,the tether has pulled on the flap 64, causing the flap 64 to lift andenable fluid from the balloon portion 50 to flow through the pressurerelease port 44, into the fluid drainage lumen 30 and out of the body.It should be understood that the flap 64 may be formed from a portion ofthe catheter shaft, such that the flap 64 has a weakened perimeter.According to an embodiment, tension applied to the flap 64 by theattached tether 62 causes the perimeter of the flap 64 to tear loosefrom the catheter shaft 20, exposing the pressure release port 44 andenabling fluid flow from the balloon portion 50 into the fluid drainagelumen 30.

As shown in FIG. 6, according to an exemplary embodiment, the releasedevice 60 can comprise a valve 66 (e.g., sliding action valve, gatevalve) between the balloon portion 50 and the fluid drainage lumen 30.The activating member may comprise the gate portion 68 of the valve 66.A substantially non-elastic tether 62 can be affixed to the gate portion68, and extend through the balloon inflation lumen 40 in a directiontoward the proximal end portion of the catheter shaft 22. In a disabledstate, the valve 66 prevents fluid in the balloon portion 50 fromflowing past the valve 66 into the fluid drainage lumen 30. In anenabling position, the valve 66 is opened (e.g., the gate is pulled backby the tether 62), enabling fluid from the balloon portion 50 to flowinto the fluid drainage lumen 30 and out of the body.

According to an exemplary embodiment, the tether 62 has a proximal endand a distal end, wherein the proximal end is affixed to the ballooninflation lumen 40 about the proximal end portion 22 of the cathetershaft 20 and the distal end of the tether is affixed to the activatingmember of the release device 60, according to an embodiment. Theproximal end of the tether 62 can be affixed to the balloon inflationlumen 40 about the balloon inflation connector 46. The proximal end ofthe tether 62 can also be affixed to a lever or switch, such thatmanipulation of the lever or switch imparts longitudinal movement of thetether within the balloon inflation lumen 40. It should be understoodthat the diameter of the tether 62 is less than the diameter of theballoon inflation lumen 40 so that fluid is able to pass through theballoon inflation lumen 40 with the tether 62 extending within.According to an exemplary embodiment, the tether 62 can comprise asemi-rigid structure that tends to prevent the balloon inflation lumenfrom kinking or otherwise becoming blocked.

FIGS. 2 and 3 illustrate how a balloon catheter apparatus 10 having aninflated balloon portion can be removed from a vessel in a human body,according to an embodiment. As shown in FIG. 2, the release device 60 ofa deflated balloon catheter is initially disabled, preventing fluid flowfrom the balloon portion 50 through the pressure release port 44. Thetether 62 maintains the activating member (e.g. plug 61) of the releasedevice 60 so that the release device is in this disabling position asthe balloon catheter apparatus 10 is inserted into a vessel and theballoon portion 50 is inflated. With the release device 60 in thedisabling position, fluid inserted into the balloon inflation lumen 40flows through the balloon inflation port 42 into the balloon portion 50,inflating the balloon portion 50.

As shown in FIG. 3, the activating member is manipulated so that therelease device 60 is enabled (e.g., the plug 61 is advanced within theballoon inflation lumen 40 past the pressure release port 42, toward theproximal end portion 22 of the catheter shaft 22), enabling fluid flowfrom the balloon portion 50 through the pressure release port 44. In theenabling position, pressurized fluid from the balloon portion 50 flowsthrough balloon inflation port 42 into the balloon inflation lumen 40,through the pressure release port 44, and into the fluid drainage lumen30, deflating the balloon portion 50. The release device 60 can beenabled by applying longitudinal force (e.g., tension) to the tether, inthe direction away from the catheter tip 21 (e.g., toward the proximalend portion 22 of the catheter shaft).

According to an exemplary embodiment, a balloon catheter apparatus 10 issecured in a vessel of a human body by an inflated balloon portion 50.When an attempt is made to withdraw the catheter shaft 20 from vessel byapplying tension to the proximal end portion 22 of the catheter shaft20, the inflated balloon portion 50 prevents removal of the distal endportion 24 of the catheter shaft from the vessel, and the catheter shaft20 stretches (e.g., lengthens). As the catheter shaft 20 lengthens, thesubstantially non-elastic tether 62, the proximal end of which issecured to the proximal end portion 22 of the catheter shaft 20,advances the plug 61 from its disabling position to its enablingposition. Once the plug 61 is in its enabling position, pressurizedfluid from the balloon portion 50 flows into the fluid drainage lumen40, deflating the balloon portion 50, and allowing withdrawal of thecatheter shaft 20 while minimizing tissue damage caused by the balloonportion 50.

Method of Deflating a Balloon Catheter

While still referring to FIGS. 1 through 7, a method of ballooncatheterization can include the act of employing a tether to activate arelease device to deflate a balloon catheter.

A method of deflating a balloon catheter apparatus 10 of the typedescribed supra can, according to an embodiment, include the acts ofproviding a balloon catheter apparatus 10 with an inflated balloonportion 50, advancing the tether 62 toward the proximal end portion 22of the catheter shaft 20 to active the release device 60, enabling fluidflow from the inflated balloon portion 50 into the fluid drainage lumen30 and out of the body, thereby deflating the balloon.

According to an embodiment, a method of deflating a balloon catheterapparatus 10 of the type described supra, includes the acts of providinga balloon catheter having an inflated balloon portion, and extending thecatheter shaft, thereby advancing the tether toward the proximal end ofthe catheter shaft to active the release device, enabling fluid flowfrom the inflated balloon portion 50 into the fluid drainage lumen 30.

The word “exemplary” is used herein to mean serving as an example,instance, or illustration. For the avoidance of doubt, the subjectmatter disclosed herein is not limited by such examples. In addition,any aspect or design described herein as “exemplary” is not necessarilyto be construed as preferred or advantageous over other aspects ordesigns, nor is it meant to preclude equivalent exemplary structures andtechniques known to those of ordinary skill in the art. Furthermore, tothe extent that the terms “includes,” “has,” “contains,” and othersimilar words are used in either the detailed description or the claims,for the avoidance of doubt, such terms are intended to be inclusive in amanner similar to the term “comprising” as an open transition wordwithout precluding any additional or other elements.

In view of the exemplary apparatus and methods described supra,methodologies that may be implemented in accordance with the disclosedsubject matter will be better appreciated with reference to theflowcharts of the various figures. While for purposes of simplicity ofexplanation, the methodologies are shown and described as a series ofblocks, it is to be understood and appreciated that the claimed subjectmatter is not limited by the order of the blocks, as some blocks mayoccur in different orders and/or concurrently with other blocks fromwhat is depicted and described herein. Moreover, not all illustratedblocks may be required to implement the methodologies describedhereinafter.

While the various embodiments have been described in connection with thepreferred embodiments of the various figures, it is to be understoodthat other similar embodiments may be used or modifications andadditions may be made to the described embodiment for performing thesame function without deviating therefrom. Therefore, the presentinvention should not be limited to any single embodiment, but rathershould be construed in breadth and scope in accordance with the appendedclaims.

1-17. (canceled)
 18. 1. A catheter comprising: an elongated tubularmember comprising a proximal end and a distal end; a fluid inletdisposed at said distal end in fluid communication with a fluid outletdisposed at said proximal end; a first lumen within said elongatedtubular member providing fluidic communication between said fluid inletand said fluid outlet; a retention balloon disposed at said distal end;a retention balloon filling inlet disposed at said proximal end; asecond lumen within said elongated tubular member providing fluidiccommunication between said retention balloon and said retention balloonfilling inlet; and a marking on said elongated tubular member, saidmarking disposed at a position indicating proper insertion amount forsaid catheter; a second balloon in fluid communication with said secondlumen, said retention balloon filling inlet and said retention balloon,wherein said second balloon is disposed distal to said retention balloonfilling inlet; wherein said elongated tubular member surrounding thesecond lumen comprises a thinned or scored region of said elongatedtubular member thereby forming said second balloon.